Table of Contents
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OPERATOR'S MANUAL
Intravascular Lithotripsy (IVL)
Generator and Connector Cable
LBL 61876 Rev E / Revision Date: March 2018
Contents
1.
Introduction ............................................................................................................................................................ 2
1.1 The IVL Generator - How Supplied .................................................................................................................................................................. 2
1.2 Required Devices and Procedure Supplies for Use with the IVL Generator .............................................................................................................. 2
1.3 Device Description ....................................................................................................................................................................................... 2
1.4 Intended Use/Indication for Use ..................................................................................................................................................................... 2
2.
Safety Information .................................................................................................................................................. 2
2.1 Terms ........................................................................................................................................................................................................ 2
2.2 Contraindications ......................................................................................................................................................................................... 2
2.3 Dangers ..................................................................................................................................................................................................... 2
2.4 Warnings .................................................................................................................................................................................................... 2
2.5 Cautions ..................................................................................................................................................................................................... 3
3.
Product Orientation ................................................................................................................................................. 3
3.1 IVL Generator - Front View ............................................................................................................................................................................ 3
3.2 Control and Indicator Functions ...................................................................................................................................................................... 4
3.3 Front Panel Connectors ................................................................................................................................................................................. 4
3.4 IVL Connector Cable ..................................................................................................................................................................................... 4
3.5 IVL Generator - Rear View ............................................................................................................................................................................ 4
4.
Product Use and Therapy Delivery .......................................................................................................................... 5
4.1 Additional Usage Information ......................................................................................................................................................................... 6
5.
Installation ............................................................................................................................................................. 7
5.1 IV Pole Mounting .......................................................................................................................................................................................... 7
5.2 Connecting to Line Power .............................................................................................................................................................................. 9
5.3 Charging the Internal Battery ......................................................................................................................................................................... 9
5.4 Environment Conditioning.............................................................................................................................................................................. 9
5.5 Generator Inspection and Test ....................................................................................................................................................................... 9
6.
Maintenance .......................................................................................................................................................... 10
6.1 Daily Maintenance .......................................................................................................................................................................................10
6.1.1
Charging and Testing the Internal Battery .............................................................................................................................................. 10
6.1.2
Testing the IVL Generator .................................................................................................................................................................... 11
6.1.3
Inspecting the IVL Generator ............................................................................................................................................................... 11
6.1.4
Cleaning the IVL Generator .................................................................................................................................................................. 11
6.2 Monthly Maintenance ...................................................................................................................................................................................11
6.3 Other Maintenance ......................................................................................................................................................................................12
6.4 Product Useful Life ......................................................................................................................................................................................12
7.
Troubleshooting .................................................................................................................................................... 12
8.
Appendix A: Electromagnetic Compatibility Guidance ........................................................................................... 13
9.
Appendix B: Symbols ............................................................................................................................................. 14
10. Appendix C: Specifications .................................................................................................................................... 15
10.1 Appendix C1: General Specifications ..............................................................................................................................................................15
10.2 Appendix C2: Performance Specifications ........................................................................................................................................................15
NOTE: This Operator's Manual provides information required for proper operation of the IVL Generator and IVL Connector Cable. Replacement IVL Connector Cables are
available from Shockwave Medical, Inc. Refer to the applicable IVL Catheter Instructions for Use (IFU) for patient treatment information.
TEXT CONVENTIONS: Throughout these operating instructions, special text characters (for example, CAPITAL LETTERS such as ON, CATH, SYS) are used to indicate
LBL 61876 rev. E, March 2018
To Be Used Exclusively with the Shockwave Medical IVL System.
controls, connectors and lighted annunciators.
EN
1
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Table of Contents
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Summary of Contents for Shockwave IVL
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Page 1: Table Of Contents
10.2 Appendix C2: Performance Specifications ................................15 NOTE: This Operator’s Manual provides information required for proper operation of the IVL Generator and IVL Connector Cable. Replacement IVL Connector Cables are available from Shockwave Medical, Inc. Refer to the applicable IVL Catheter Instructions for Use (IFU) for patient treatment information. -
Page 2: Introduction
SHOCK OR FIRE HAZARD Do not immerse any portion of the IVL Generator in water or other fluids. Do not immerse IVL Connector Cables in water or other fluids. Avoid spilling any fluids on the IVL Generator. Spilled liquids may cause the IVL Generator to perform inaccurately or malfunction. Do not clean with solvents or flammable agents as this may cause damage to the IVL Generator and possibly cause harm to the user. -
Page 3: Cautions
GENERAL CAUTIONS The Shockwave Medical IVL System is intended for use by a physician, or on the order of, a physician. Prior to using the IVL Generator, the user should be familiar with the controls and functions of the system described in this manual. Do not press more than one button at a time on the IVL Generator. The IVL Generator may not respond to either user input. If the shipping container has been damaged in transit or if any part of this product appears damaged, cracked, chipped or missing, remove from use and contact your Shockwave Medical representative for repair or replacement. -
Page 4: Control And Indicator Functions
IVL Connector Cable Pressing and holding the THERAPY CONTROL on the IVL Connector Cable initiates therapy delivery. The IVL Generator must first be activated (THERAPY STATUS indicators on IVL Generator front panel and CATHETER CONNECTOR will be green). Refer to Section 4.0, Step 8 for more information. -
Page 5: Product Use And Therapy Delivery
Before use read all sections of this operator’s manual and familiarize yourself with all controls, displays and connector features. Charge the IVL Generator before use (see Sections 5.2, 5.3). Also refer to the IFU provided with the IVL Catheter for additional information before use. Not all clinical procedures will follow the sequence below. The following steps serve as a guide for use of the IVL Generator in clinical applications. -
Page 6: Additional Usage Information
Additional Usage Information The following topics and additional information may be useful in the use of the IVL Generator in treatment scenarios that may differ from the basic sequence of events defined in Section 4.0 above. -
Page 7: Installation
Important - Follow all steps in Sections 5.0 – 5.5 prior to use of this product. The IVL Generator is shipped as an assembled product, ready to install on an IV pole as outlined in Section 1.1. It is designed to be mounted to an IV pole prior to use. - Page 8 STEP 4 – Mount the IVL Generator to the top bracket: Align the holes in the mounting plate on the right side of the IVL Generator with the bracket mounting studs. Push the IVL Generator towards the bracket to engage the mounting studs then push the IVL Generator down to lock in place.
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Page 9: Connecting To Line Power
The IVL Generator normally operates from an internal, rechargeable battery system. However, in order to charge the battery system, the Charger Module must first be connected to line power. Locate the AC Mains Cable shipped with the IVL Generator and connect it to the AC Mains input as indicated in the figure on the next page. Choose a safe location where connection of this power cable to AC Mains will not create a trip hazard and connect it to the AC Mains outlet. -
Page 10: Maintenance
This is the final step of the recommended inspection and test procedure. WARNING – SHOCK HAZARD Do not immerse IVL Connector Cables in water or other fluids. Avoid spilling any fluids on the IVL Generator. Spilled liquids may cause the IVL Generator to perform inaccurately or malfunction. -
Page 11: Testing The Ivl Generator
WARNING – SHOCK OR FIRE HAZARD Do not immerse any portion of the IVL Generator in water or other fluids. Do not immerse IVL Connector Cables in water or other fluids. Avoid spilling any fluids on the IVL Generator. Spilled liquids may cause the IVL Generator to perform inaccurately or malfunction. -
Page 12: Other Maintenance
7. Troubleshooting If a problem is detected with the IVL System during use or testing, refer to the troubleshooting tips below. If the problem cannot be corrected, remove the equipment from service and contact your Shockwave Medical representative and or email complaints@shockwavemedical.com. -
Page 13: Appendix A: Electromagnetic Compatibility Guidance
8. Appendix A: Electromagnetic Compatibility Guidance Electromagnetic Compatibility Guidance - Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Generator Model 825DP is intended for use in the electromagnetic environment specified below. The customer or the user of the Generator Model 825DP should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –... -
Page 14: Appendix B: Symbols
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Essential Performance Generator Model 825DP maintains safe and effective performance in the delivery of IVL therapy when operated in the electromagnetic environment specified in the table above. -
Page 15: Appendix C: Specifications
The open circuit voltage at the IVL Generator THERAPY CONNECTOR: 5% of pre-programmed set point. Output Limits IVL System is designed to override user input and limit the number of continuous pulses delivered based on the IVL Catheter model connected. Refer to IVL Catheter IFU. - Page 16 PN 62393 Rev A Manufactured by Shockwave Medical, Inc. 48501 Warm Springs Blvd., Suite 108 Fremont, CA 94539, USA www.shockwavemedical.com/patents MedPass SAS 95 bis Boulevard Pereire 75017 Paris France...
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